How Translational Bioinformatics and Digital Health will contribute to increased opportunities for patients to participate in clinical trials
The political paper “Action Plan for Clinical Studies (2021–2025)” was recently released in Norway by the Ministry of Health and Care Services, presenting 9 areas of focus.
This is post number 2 in a 4 posts-series where I present some of the opportunities that lie in Translational Bioinformatics and Digital Health, for increased opportunities for patients to participate in clinical trials.
The patient’s needs and experiences should be included in prioritisation, planning, and conducting clinical trials.
Patients must be given more accessible and user-friendly access to clinical studies and information about their own participation in clinical studies.
Over the past years, I’ve worked with PubGene AS to develop Coremine Vitae to help people diagnosed with cancer, autoimmune and neurodegenerative diseases find the best treatment options. Sometimes, accessing the best possible treatment means enrolling on a clinical study, and this can be a difficult choice for clinician and patient. To help the shared decision, we designed patient-friendly reports delivered in multidisciplinary meetings with molecular and data scientists, healthcare professionals and the patient. The shared decision implies a reduction in decisional conflict related to feeling uninformed and indecision about personal values.
With Coremine Vitae, we intend to show that better-informed patients translate into increased engagement into the right clinical studies and reduced inappropriate variations in clinical practice.
The solution builds on the following best practices:
1. Shared decision-making in medicine (SDM) is a process whereby patients together with their clinician discuss the current evidence on options and arrive at a mutually agreed-on choice (Charles c, 1997; Towle A, 1999, Elwyn G, 2001).
2. Patient decision aids (PtDAs) are interventions designed to help patients discuss treatment options with their clinicians and make specific, deliberative choices. The aim of PtDAs is to improve decision quality and to reduce unwarranted practice variations.
3. The International Patient Decision Aid Standards (IPDAS) checklist designed to be used by developers, patients, health care professionals, health care insurers, administrators, policy makers, and researchers to critically appraise individual decision aids or to compare across available decision aids on the same topic.
Coremine Vitae is certified as a Medical Device software. As part of the clinical evaluation effort, I identified — through a comprehensive literature review and evaluation of comparative devices — factors that must be incorporated in the design of decision aids for successul and safe implementation.
Those factors influence the successful implementation of decision aids:
- reminders in the scheduling system (Dawn Stacey et al., 2008)
- patient decision aids integrated with patient flow through the clinic (Dawn Stacey et al., 2008)
- physicians recommending the patient decision aids (Dawn Stacey et al., 2008)
- disease-matching health education to patients with lower education levels (Chang, Li, & Lin, 2019)
- personalisation of info associated with outcomes and side-effects (R. D. Vromans et al., 2019)
- exercises that help patients clarify their values and preferences (R. D. Vromans et al., 2019)
- both short and elaborated versions of decision aids (R. D. Vromans et al., 2019)
- dynamic updates based on new evidence and patient data (R. D. Vromans et al., 2019)
- reliable sources of information (R. D. Vromans et al., 2019)
Decentralised studies give patients access to clinical trials where patients are.
An increase in decentralised studies will result in the increased solicitation of the primary digital physician and the local healthcare team to follow up on the patient.
Digital Personalised Patient Pathways that consider the clinical and research options will empower the healthcare team with a concise, yet complete picture of the patient healthcare journey, past and future options, potential side effects of treatments and know when patient should opt-out of an ineffective treatment.
We combine translational bioinformatics algorithms and human expertise to generate personalised patient pathways.
We want to present those pathways in a digital health tool for easy information navigation. That we why we are now building Vitae Evidence and Personalised Medicine Insights APIs.
Decentralised studies will require the adoption of Virtual Trials solutions.
Decentralised studies or satellite studies also means increased usage of virtual trial software. We built our solution on CheckWare, a secure web-based remote monitoring portal for patient participation. This tool is broadly used by the Norwegian Healthcare Regions. We hope that this will lower the barriers to digital health for personalised medicine adoption by clinicians, researchers, and patients.
Coming next in this series: Better use of health data in clinical trials. Until then, don’t hesitate to comment below if you have any questions. Maybe you would like to share additional Digital Health and bioinformatics solutions that can improve patient participation in clinical studies?
In case you’ve missed the previous articles:
